Tocilizumab-aazg for Brain Aneurysm

(THRIVE Trial)

Overseen By Brian Hoh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Florida

Must not be taking: IL-6 inhibitors, Anti-CD20, others

Disqualifiers: Vasospasm, Hemodynamic instability, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been treated with certain medications like IL-6 inhibitors or other specific therapies within a certain timeframe before the trial, you may not be eligible to participate.

What data supports the effectiveness of the drug Tocilizumab-aazg for treating brain aneurysms?

Tocilizumab, a drug similar to Tocilizumab-aazg, has been effective in treating conditions like giant cell arteritis and Takayasu arteritis, which are diseases involving inflammation of blood vessels. This suggests it might help with brain aneurysms, which also involve blood vessels. ^{1 2 3 4 5}

What is the purpose of this trial?

In this study, tocilizumab-aazg (TYENNE) will be administered to see whether tocilizumab-aazg is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm.

Research Team

Brian Hoh, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for patients who've had a burst brain aneurysm, which can lead to subarachnoid hemorrhage and increase the risk of stroke and cognitive issues. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I have or will have a drain placed in my head or spine.

I am a woman able to have children and my pregnancy test is negative.

Signed informed consent from subject or legally authorized representative

Exclusion Criteria

I do not have active or untreated TB or lung disease.

I do not have any current infections.

Illicit drug or alcohol abuse within 12 months prior to screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive tocilizumab-aazg 6mg/kg IV infusion drip on Day 0 following subarachnoid hemorrhage

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and laboratory measures

90 days

Treatment Details

Interventions

• Tocilizumab-aazg

Trial Overview The study tests tocilizumab-aazg (TYENNE), focusing on its safety in those with a recent burst brain aneurysm and its potential to prevent further strokes or cerebral ischemia following such an event.

Participant Groups

Group I: tocilizumab-aazg (TYENNE) Experimental Treatment 1 Intervention

Participants will receive tocilizumab-aazg 6mg/kg IV infusion drip on Day 0 following subarachnoid hemorrhage and enrollment in the trial.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of anti-interleukin 6 receptor monoclonal antibody (tocilizumab) in Colombian patients with Takayasu arteritis. [2016]

2. England pubmed.ncbi.nlm.nih.gov

A multicentre, large-scale, observational study of tocilizumab in patients with giant cell arteritis in Japan. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Tocilizumab in Giant Cell Arteritis: A Multicenter Retrospective Study of 34 Patients. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Optimisation of tocilizumab therapy in giant cell arteritis. A multicentre real-life study of 471 patients. [2023]

5. England pubmed.ncbi.nlm.nih.gov

AA amyloidosis treated with tocilizumab: case series and updated literature review. [2016]